Phase 1 Study of Ziftomenib Combined With VenetoclaxAzacitidine or Standard Induction Chemotherapy 73 With or Without Quizartinib for Treating Acute Myeloid Leukemia Patients

What this Trial Is About

Researchers are studying ziftomenib, an investigational oral drug, in combination with standard treatments for patients with acute myeloid leukemia AML who have specific genetic mutations such as NPM1 or KMT2A rearrangements. This Phase 1 trial aims to assess the safety, tolerability, and early signs of effectiveness of ziftomenib when added to existing AML therapies in both newly diagnosed and relapsedrefractory patients. The study includes several treatment groups where ziftomenib is combined with drugs like venetoclax, azacitidine, daunorubicin, cytarabine, and quizartinib. Patients receive these medications through oral, intravenous, or subcutaneous routes depending on the combination. Different arms focus on distinct patient groups based on genetic markers and prior treatment history. The study investigates dose levels and combinations including intensive chemotherapy regimens and targeted therapies over multiple treatment cycles. Participants will be monitored closely from the first day of treatment through up to 36 months, with regular assessments of side effects, blood tests, and response to therapy including remission rates. Researchers will track dose-limiting toxicities and adverse events, as well as disease outcomes like complete remission and measurable residual disease. Safety and effectiveness data will be collected through a series of treatment cycles, with follow-up continuing for up to three years to evaluate long-term impact and survival outcomes.

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML